MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE® VERSATIE SYSTEM; BONE FIXATION CERCLAGE, SUBLAMINAR

Model Number 8550002

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cancer (3262)

Event Date 04/04/2017

Event Type  Injury  

Manufacturer Narrative

No product has been returned for investigation, nor were radiographs provided to confirm the reported event.Labeling review: "as with any major surgical procedures, there are risks involved in orthopedic surgery." "potential risks identified with the use of this system, which may require additional surgery, include: implants cutting through soft osteoporotic, osteolienic or cancellous bone." no product returned.

Event Description

Information received states laminar band sawed through bone tissue.No other event information has been provided or radiographs that confirm the reported event.No revision procedure was reported.

Manufacturer Narrative

Received information stating lamina breakage was unrelated to product malfunction.Posterior fixation was applied and laminectomy was completed.No revision procedure was required.

• Brand Name: NUVASIVE® VERSATIE SYSTEM
• Type of Device: BONE FIXATION CERCLAGE, SUBLAMINAR
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: yobana sanchez ; 7475 lusk blvd; san diego, CA 92121 ; 8589093383
• MDR Report Key: 7007365
• MDR Text Key: 91292280
• Report Number: 2031966-2017-00163
• Device Sequence Number: 1
• Product Code: OWI
• UDI-Device Identifier: 00887517721525
• UDI-Public: 00887517721525
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161265
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 8550002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR